{ "article": { "LEGIARTI000018776012": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5141-19", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2023-11-25", "DATE_DEBUT": "2008-05-08" } }, "META_COMMUN": { "ID": "LEGIARTI000018776012", "URL": "article/LEGI/ARTI/00/00/18/77/60/LEGIARTI000018776012.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000018769246", "@num": "3", "#text": "Décret n°2008-433\n du 6 mai 2008 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000018767743", "@nortexte": "SJSP0807006D", "@numtexte": "2008-433", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2008-05-06" }, { "@id": "LEGIARTI000048454147", "@num": "1", "#text": "Décret n°2023-1079 du 22 novembre 2023 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000048453209", "@nortexte": "AGRG2318778D", "@numtexte": "2023-1079", "@typelien": "ABROGE", "@naturetexte": "DECRET", "@datesignatexte": "2023-11-22" }, { "@id": "LEGIARTI000006690188", "@num": "L5141-2", "#text": "Code de la santé publique - art. L5141-2", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915813", "@num": "R5141-16", "#text": "Code de la santé publique - art. R5141-16", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915815", "@num": "R5141-18", "#text": "Code de la santé publique - art. R5141-18", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800813", "@num": "R5146-30", "#text": "Code de la santé publique - art. R5146-30 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800811", "@num": "R5146-30", "#text": "Code de la santé publique - art. R5146-30 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006196626", "@fin": "2023-11-25", "#text": "Sous-section 1 : Instruction de la demande.", "@debut": "2004-08-08" }, { "@id": "LEGISCTA000048457260", "@fin": "2999-01-01", "#text": "Sous-section 1 : Modification du titulaire", "@debut": "2023-11-25" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006190718", "@fin": "2023-11-25", "#text": "Section 3 : Autorisation de mise sur le marché", "@debut": "2004-08-08" }, { "@id": "LEGISCTA000048457262", "@fin": "2999-01-01", "#text": "Section 3 : Dispositions communes aux médicaments vétérinaires autorisés et enregistrés", "@debut": "2023-11-25" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178661", "@fin": "2999-01-01", "#text": "Chapitre Ier : Dispositions générales", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161014", "@fin": "2999-01-01", "#text": "Titre IV : Médicaments vétérinaires", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145489", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132399", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006112927", "@fin": "2999-01-01", "#text": "Partie réglementaire", "@debut": "2000-12-23" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006915816", "@fin": "2008-05-08", "@num": "R5141-19", "@etat": "MODIFIE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000018776012", "@fin": "2023-11-25", "@num": "R5141-19", "@etat": "ABROGE", "@debut": "2008-05-08", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Les dossiers fournis à l'appui de l'autorisation des médicaments vétérinaires mentionnés aux articles R. 5141-16 et R. 5141-18 sont considérés comme comportant l'ensemble des données nécessaires et suffisantes pour l'évaluation de ces médicaments au sens du 8° de l'article L. 5141-2.

" } }, "LEGIARTI000006690188": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5141-2", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2007-04-27", "DATE_DEBUT": "2000-06-22" } }, "META_COMMUN": { "ID": "LEGIARTI000006690188", "URL": "article/LEGI/ARTI/00/00/06/69/01/LEGIARTI000006690188.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5141L02XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006207056", "@num": "1", "#text": "Arrêté du 18 décembre 2001 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000215293", "@nortexte": "AGRG0102675A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2001-12-18" }, { "@id": "JORFTEXT000000227015", "#text": "Loi 2002-303 2002-03-04 art. 92 JORF 5 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000006209506", "@num": "1", "#text": "Arrêté du 7 mars 2002 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000217836", "@nortexte": "AGRG0200239A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2002-03-07" }, { "@id": "LEGITEXT000005764961", "#text": "Arrêté du 2 décembre 2003", "@sens": "cible", "@cidtexte": "JORFTEXT000000798573", "@nortexte": "AGRG0302575A", "@typelien": "TXT_SOURCE", "@naturetexte": "ARRETE", "@datesignatexte": "2003-12-02" }, { "@id": "LEGIARTI000006227830", "@num": "1", "#text": "Arrêté du 2 décembre 2003 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000798573", "@nortexte": "AGRG0302575A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2003-12-02" }, { "@id": "LEGIARTI000006227830", "@num": "1", "#text": "Arrêté du 2 décembre 2003 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000798573", "@nortexte": "AGRG0302575A", "@typelien": "TXT_SOURCE", "@naturetexte": "ARRETE", "@datesignatexte": "2003-12-02" }, { "@id": "LEGIARTI000006227831", "@num": "2", "#text": "Arrêté du 2 décembre 2003 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000798573", "@nortexte": "AGRG0302575A", "@typelien": "TXT_SOURCE", "@naturetexte": "ARRETE", "@datesignatexte": "2003-12-02" }, { "@id": "LEGIARTI000006733878", "@num": "ANNEXE", "#text": "Arrêté du 9 juin 2004 - art. ANNEXE (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000255672", "@nortexte": "SANP0422019A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2004-06-09" }, { "@id": "LEGIARTI000006734074", "@num": "ANNEXE", "#text": "Arrêté du 21 avril 2005 - art. ANNEXE (VT)", "@sens": "cible", "@cidtexte": "JORFTEXT000000627974", "@nortexte": "SANP0521551A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2005-04-21" }, { "@id": "LEGIARTI000019279088", "@num": "12", "#text": "LOI n°2008-757\n du 1er août 2008 - art. 12 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000019277729", "@nortexte": "DEVX0700028L", "@numtexte": "2008-757", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2008-08-01" }, { "@id": "LEGIARTI000025882819", "#text": "Arrêté du 1er septembre 2009 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000021021310", "@nortexte": "SASP0920309A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-09-01" }, { "@id": "LEGIARTI000033960696", "@num": "1", "#text": "Arrêté du 14 novembre 2016 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033956149", "@nortexte": "AGRG1634102A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-11-14" }, { "@id": "LEGIARTI000006689866", "@num": "L5111-1", "#text": "Code de la santé publique - art. L5111-1 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690218", "@num": "L5141-11", "#text": "Code de la santé publique - art. L5141-11 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690225", "@num": "L5141-15", "#text": "Code de la santé publique - art. L5141-15 (T)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000047291490", "@num": "L5141-16", "#text": "Code de la santé publique - art. L5141-16 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021666229", "@num": "L5141-5-3", "#text": "Code de la santé publique - art. L5141-5-3 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021941917", "@num": "L5141-5-4", "#text": "Code de la santé publique - art. L5141-5-4 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045405162", "@num": "L5142-4", "#text": "Code de la santé publique - art. L5142-4 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045405438", "@num": "L5441-6", "#text": "Code de la santé publique - art. L5441-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693777", "@num": "L607", "#text": "Code de la santé publique - art. L607 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693774", "@num": "L607", "#text": "Code de la santé publique - art. L607 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033642625", "@num": "R1341-10", "#text": "Code de la santé publique - art. R1341-10 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000043335118", "@num": "R1342-20", "#text": "Code de la santé publique - art. R1342-20 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915228", "@num": "R5125-46", "#text": "Code de la santé publique - art. R5125-46 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000022292440", "@num": "R5141-141", "#text": "Code de la santé publique - art. R5141-141 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018776012", "@num": "R5141-19", "#text": "Code de la santé publique - art. R5141-19 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916131", "@num": "R5142-45", "#text": "Code de la santé publique - art. R5142-45 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800687", "@num": "R5145-37", "#text": "Code de la santé publique - art. R5145-37 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025378819", "@num": "R5161-1", "#text": "Code de la santé publique - art. R5161-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171385", "@fin": "2999-01-01", "#text": "Chapitre Ier : Dispositions générales.", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155087", "@fin": "2999-01-01", "#text": "Titre IV : Médicaments vétérinaires", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140630", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125349", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690188", "@fin": "2007-04-27", "@num": "L5141-2", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690189", "@fin": "2009-02-28", "@num": "L5141-2", "@etat": "MODIFIE", "@debut": "2007-04-27", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000020317411", "@fin": "2010-02-26", "@num": "L5141-2", "@etat": "MODIFIE", "@debut": "2009-02-28", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000021941924", "@fin": "2011-06-18", "@num": "L5141-2", "@etat": "MODIFIE", "@debut": "2010-02-26", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000024198071", "@fin": "2022-03-25", "@num": "L5141-2", "@etat": "MODIFIE", "@debut": "2011-06-18", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000045405073", "@fin": "2999-01-01", "@num": "L5141-2", "@etat": "VIGUEUR", "@debut": "2022-03-25", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
On entend par :
\n
1° Médicament vétérinaire préfabriqué, tout médicament vétérinaire préparé à l'avance, présenté sous une forme pharmaceutique utilisable sans transformation ;
\n
2° Médicament vétérinaire immunologique, tout médicament vétérinaire administré en vue de provoquer une immunité active ou passive ou de diagnostiquer l'état d'immunité ;
\n
3° Autovaccin à usage vétérinaire, tout médicament vétérinaire immunologique fabriqué en vue de provoquer une immunité active à partir d'organismes pathogènes provenant d'un animal ou d'animaux d'un même élevage, inactivés et utilisés pour le traitement de cet animal ou des animaux de cet élevage ;
\n
4° Prémélange médicamenteux, tout médicament vétérinaire préparé à l'avance et exclusivement destiné à la fabrication ultérieure d'aliments médicamenteux ;
\n
5° Aliment médicamenteux, tout médicament vétérinaire constitué à partir d'un mélange d'aliment et de prémélange médicamenteux, présenté pour être administré aux animaux sans transformation dans un but thérapeutique, préventif ou curatif, au sens de l'alinéa premier de l'article L. 5111-1 ;
\n
6° Médicament vétérinaire antiparasitaire, tout produit antiparasitaire à usage vétérinaire ;
\n
7° Médicament homéopathique vétérinaire, tout médicament vétérinaire obtenu à partir de produits, substances ou compositions appelés souches homéopathiques, selon un procédé de fabrication homéopathique décrit par la pharmacopée européenne, la pharmacopée française ou, à défaut, par les pharmacopées utilisées de façon officielle dans un autre Etat membre de la Communauté européenne ; un médicament homéopathique vétérinaire peut aussi contenir plusieurs principes.
" } }, "LEGIARTI000006690189": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5141-2", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2009-02-28", "DATE_DEBUT": "2007-04-27" } }, "META_COMMUN": { "ID": "LEGIARTI000006690189", "URL": "article/LEGI/ARTI/00/00/06/69/01/LEGIARTI000006690189.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5141L02XXAB" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006207056", "@num": "1", "#text": "Arrêté du 18 décembre 2001 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000215293", "@nortexte": "AGRG0102675A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2001-12-18" }, { "@id": "JORFTEXT000000227015", "#text": "Loi 2002-303 2002-03-04 art. 92 JORF 5 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000006209506", "@num": "1", "#text": "Arrêté du 7 mars 2002 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000217836", "@nortexte": "AGRG0200239A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2002-03-07" }, { "@id": "LEGITEXT000005764961", "#text": "Arrêté du 2 décembre 2003", "@sens": "cible", "@cidtexte": "JORFTEXT000000798573", "@nortexte": "AGRG0302575A", "@typelien": "TXT_SOURCE", "@naturetexte": "ARRETE", "@datesignatexte": "2003-12-02" }, { "@id": "LEGIARTI000006227830", "@num": "1", "#text": "Arrêté du 2 décembre 2003 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000798573", "@nortexte": "AGRG0302575A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2003-12-02" }, { "@id": "LEGIARTI000006227830", "@num": "1", "#text": "Arrêté du 2 décembre 2003 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000798573", "@nortexte": "AGRG0302575A", "@typelien": "TXT_SOURCE", "@naturetexte": "ARRETE", "@datesignatexte": "2003-12-02" }, { "@id": "LEGIARTI000006227831", "@num": "2", "#text": "Arrêté du 2 décembre 2003 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000798573", "@nortexte": "AGRG0302575A", "@typelien": "TXT_SOURCE", "@naturetexte": "ARRETE", "@datesignatexte": "2003-12-02" }, { "@id": "LEGIARTI000006733878", "@num": "ANNEXE", "#text": "Arrêté du 9 juin 2004 - art. 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On entend par :

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1° (Abrogé) ;

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2° Médicament vétérinaire immunologique, tout médicament vétérinaire administré en vue de provoquer une immunité active ou passive ou de diagnostiquer l'état d'immunité, ou tout allergène, défini comme tout produit destiné à identifier ou à provoquer une modification spécifique et acquise de la réponse immunologique à un agent allergisant ;

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3° Autovaccin à usage vétérinaire, tout médicament vétérinaire immunologique fabriqué en vue de provoquer une immunité active à partir d'organismes pathogènes provenant d'un animal ou d'animaux d'un même élevage, inactivés et utilisés pour le traitement de cet animal ou des animaux de cet élevage ;

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4° Prémélange médicamenteux, tout médicament vétérinaire préparé à l'avance et exclusivement destiné à la fabrication ultérieure d'aliments médicamenteux ;

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5° Aliment médicamenteux, tout médicament vétérinaire constitué à partir d'un mélange d'aliment et de prémélange médicamenteux, présenté pour être administré aux animaux sans transformation dans un but thérapeutique, préventif ou curatif, au sens de l'alinéa premier de l'article L. 5111-1 ;

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6° Médicament vétérinaire antiparasitaire, tout produit antiparasitaire à usage vétérinaire ;

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7° Médicament homéopathique vétérinaire, tout médicament vétérinaire obtenu à partir de substances appelées, souches homéopathiques, selon un procédé de fabrication homéopathique décrit par la pharmacopée européenne, la pharmacopée française ou, à défaut, par les pharmacopées utilisées de façon officielle dans un autre Etat membre de la Communauté européenne ; un médicament homéopathique vétérinaire peut aussi contenir plusieurs principes ;

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8° Médicament générique vétérinaire, tout médicament vétérinaire qui, sans préjudice des dispositions des articles L. 611-2 et suivants du code de la propriété intellectuelle, a la même composition qualitative et quantitative en principes actifs et la même forme pharmaceutique qu'un médicament vétérinaire dit de référence et dont la bioéquivalence avec le médicament de référence est démontrée par des études de biodisponibilité appropriées. Un médicament vétérinaire ne peut être qualifié de médicament de référence que si son autorisation de mise sur le marché a été délivrée au vu d'un dossier comportant, dans des conditions fixées par voie réglementaire, l'ensemble des données nécessaires et suffisantes à elles seules pour son évaluation. Pour l'application du présent alinéa, les différentes formes pharmaceutiques orales à libération immédiate sont considérées comme une même forme pharmaceutique. De même, les différents sels, esters, éthers, isomères, mélanges d'isomères, complexes ou dérivés d'un principe actif sont regardés comme ayant la même composition qualitative en principe actif, sauf s'ils présentent des propriétés sensiblement différentes au regard de la sécurité ou de l'efficacité. Dans ce cas, des informations supplémentaires fournissant la preuve de la sécurité et de l'efficacité des différents sels, esters ou dérivés d'une substance active autorisée doivent être données par le demandeur de l'autorisation de mise sur le marché ;

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9° Médicament biologique vétérinaire, tout médicament vétérinaire dont la substance active est produite à partir d'une source biologique ou en est extraite et dont la caractérisation et la détermination de la qualité nécessitent une combinaison d'essais physiques, chimiques et biologiques ainsi que la connaissance de son procédé de fabrication et de contrôle ;

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10° Médicament biologique vétérinaire similaire, tout médicament biologique vétérinaire qui, sans préjudice des dispositions des articles L. 611-2 et suivants du code de la propriété intellectuelle, a la même composition qualitative et quantitative en substance active et la même forme pharmaceutique qu'un médicament vétérinaire biologique de référence mais qui ne remplit pas les conditions prévues au 8° du présent article pour être regardé comme un médicament générique vétérinaire en raison de différences liées notamment à la variabilité de la matière première ou aux procédés de fabrication et nécessitant que soient produites des données précliniques et cliniques supplémentaires dans des conditions déterminées par voie réglementaire ;

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11° Préparation extemporanée vétérinaire, tout médicament vétérinaire qui est préparé au moment de son utilisation ;

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12° Préparation magistrale vétérinaire, toute préparation extemporanée vétérinaire réalisée selon une prescription destinée à un animal ou à des animaux d'une même exploitation ;

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13° Préparation officinale vétérinaire, tout médicament vétérinaire préparé en pharmacie inscrit à la pharmacopée ou au formulaire national et destiné à être délivré directement à l'utilisateur final ;

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14° Temps d'attente, la période nécessaire entre la dernière administration du médicament vétérinaire à l'animal dans les conditions normales d'emploi et l'obtention des denrées alimentaires provenant de cet animal, afin de protéger la santé publique, en garantissant que de telles denrées alimentaires ne contiennent pas de résidus en quantités supérieures aux limites maximales de résidus des substances pharmacologiquement actives, telles que fixées en vertu du règlement du Conseil (CEE) n° 2377/90 du 26 juin 1990 modifié établissant une procédure communautaire pour la fixation des limites maximales de résidus de médicaments vétérinaires dans les aliments d'origine animale.

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" } }, "LEGIARTI000006915813": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5141-16", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2008-05-08", "DATE_DEBUT": "2004-08-08" } }, "META_COMMUN": { "ID": "LEGIARTI000006915813", "URL": "article/LEGI/ARTI/00/00/06/91/58/LEGIARTI000006915813.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "YXXXXXXXXXX5141R0160XX0A" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000025882819", "#text": "Arrêté du 1er septembre 2009 - art. 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D5141-55 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000044911118", "@num": "D5141-56", "#text": "Code de la santé publique - art. D5141-56 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000031216668", "@num": "D5141-56-1", "#text": "Code de la santé publique - art. D5141-56-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000044911106", "@num": "D5141-57", "#text": "Code de la santé publique - art. D5141-57 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048457242", "@num": "R5141-13", "#text": "Code de la santé publique - art. R5141-13 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018776021", "@num": "R5141-17", "#text": "Code de la santé publique - art. R5141-17 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000030773933", "@num": "R5141-18", "#text": "Code de la santé publique - art. R5141-18 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018776012", "@num": "R5141-19", "#text": "Code de la santé publique - art. R5141-19 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000027859880", "@num": "R5141-20", "#text": "Code de la santé publique - art. R5141-20 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800804", "@num": "R5146-28", "#text": "Code de la santé publique - art. R5146-28 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800802", "@num": "R5146-28", "#text": "Code de la santé publique - art. R5146-28 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006196626", "@fin": "2023-11-25", "#text": "Sous-section 1 : Instruction de la demande.", "@debut": "2004-08-08" }, { "@id": "LEGISCTA000048457260", "@fin": "2999-01-01", "#text": "Sous-section 1 : Modification du titulaire", "@debut": "2023-11-25" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006190718", "@fin": "2023-11-25", "#text": "Section 3 : Autorisation de mise sur le marché", "@debut": "2004-08-08" }, { "@id": "LEGISCTA000048457262", "@fin": "2999-01-01", "#text": "Section 3 : Dispositions communes aux médicaments vétérinaires autorisés et enregistrés", "@debut": "2023-11-25" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178661", "@fin": "2999-01-01", "#text": "Chapitre Ier : Dispositions générales", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161014", "@fin": "2999-01-01", "#text": "Titre IV : Médicaments vétérinaires", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145489", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132399", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006112927", "@fin": "2999-01-01", "#text": "Partie réglementaire", "@debut": "2000-12-23" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006915813", "@fin": "2008-05-08", "@num": "R5141-16", "@etat": "MODIFIE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000018776026", "@fin": "2009-06-21", "@num": "R5141-16", "@etat": "MODIFIE", "@debut": "2008-05-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000020775665", "@fin": "2011-04-14", "@num": "R5141-16", "@etat": "MODIFIE", "@debut": "2009-06-21", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000023860648", "@fin": "2023-11-25", "@num": "R5141-16", "@etat": "ABROGE", "@debut": "2011-04-14", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
A la demande est joint un dossier comprenant :
\n
1° Les documentations relatives aux essais non cliniques, à savoir les essais analytiques, les essais d'innocuité, l'étude des résidus et les essais précliniques et celles relatives aux essais cliniques et aux essais d'efficacité mentionnés aux articles R. 5141-18 à R. 5141-21, incluant les résultats obtenus au cours des différents essais réalisés ;
\n
2° Les rapports d'experts relatifs à ces documentations ;
\n
3° Le cas échéant, une copie :
\n
a) Des autorisations de mise sur le marché obtenues pour ce médicament, soit dans un Etat membre de la Communauté européenne, soit dans un pays tiers, accompagnées des résumés des caractéristiques du produit ;
\n
b) Des décisions de refus d'autorisation de mise sur le marché de ce médicament ainsi que de leurs motifs ;
\n
c) Des demandes d'autorisation de mise sur le marché en cours d'examen dans les Etats membres de la Communauté européenne ou les Etats parties à l'accord sur l'Espace économique européen, accompagnées des résumés des caractéristiques du produit et des notices proposés ;
\n
d) De la demande présentée à la Commission des Communautés européennes conformément à l'annexe V du règlement du Conseil (CEE) n° 2377/90 du 26 juin 1990 établissant une procédure pour la fixation des limites maximales de résidus de médicaments vétérinaires dans les aliments d'origine animale, lorsque le médicament contient un ou plusieurs principes actifs nouveaux qui ne sont pas mentionnés aux annexes I, II ou III de ce règlement.
" } }, "LEGIARTI000006915815": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5141-18", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2008-05-08", "DATE_DEBUT": "2004-08-08" } }, "META_COMMUN": { "ID": "LEGIARTI000006915815", "URL": "article/LEGI/ARTI/00/00/06/91/58/LEGIARTI000006915815.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "YXXXXXXXXXX5141R0180XX0A" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000025882819", "#text": "Arrêté du 1er septembre 2009 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000021021310", "@nortexte": "SASP0920309A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-09-01" }, { "@id": "LEGIARTI000044911130", "@num": "D5141-55", "#text": "Code de la santé publique - art. D5141-55 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000044911118", "@num": "D5141-56", "#text": "Code de la santé publique - art. D5141-56 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000031216668", "@num": "D5141-56-1", "#text": "Code de la santé publique - art. D5141-56-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000044911106", "@num": "D5141-57", "#text": "Code de la santé publique - art. D5141-57 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018776012", "@num": "R5141-19", "#text": "Code de la santé publique - art. R5141-19 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018775997", "@num": "R5141-23", "#text": "Code de la santé publique - art. R5141-23 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000023860120", "@num": "R5141-80", "#text": "Code de la santé publique - art. R5141-80 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800810", "@num": "R5146-29", "#text": "Code de la santé publique - art. R5146-29 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800807", "@num": "R5146-29", "#text": "Code de la santé publique - art. R5146-29 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006196626", "@fin": "2023-11-25", "#text": "Sous-section 1 : Instruction de la demande.", "@debut": "2004-08-08" }, { "@id": "LEGISCTA000048457260", "@fin": "2999-01-01", "#text": "Sous-section 1 : Modification du titulaire", "@debut": "2023-11-25" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006190718", "@fin": "2023-11-25", "#text": "Section 3 : Autorisation de mise sur le marché", "@debut": "2004-08-08" }, { "@id": "LEGISCTA000048457262", "@fin": "2999-01-01", "#text": "Section 3 : Dispositions communes aux médicaments vétérinaires autorisés et enregistrés", "@debut": "2023-11-25" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178661", "@fin": "2999-01-01", "#text": "Chapitre Ier : Dispositions générales", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161014", "@fin": "2999-01-01", "#text": "Titre IV : Médicaments vétérinaires", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145489", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132399", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006112927", "@fin": "2999-01-01", "#text": "Partie réglementaire", "@debut": "2000-12-23" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006915815", "@fin": "2008-05-08", "@num": "R5141-18", "@etat": "MODIFIE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000018776017", "@fin": "2011-08-29", "@num": "R5141-18", "@etat": "MODIFIE", "@debut": "2008-05-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000024516430", "@fin": "2014-02-01", "@num": "R5141-18", "@etat": "MODIFIE", "@debut": "2011-08-29", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000027859857", "@fin": "2015-06-25", "@num": "R5141-18", "@etat": "MODIFIE", "@debut": "2014-02-01", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000030773933", "@fin": "2023-11-25", "@num": "R5141-18", "@etat": "ABROGE", "@debut": "2015-06-25", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
La documentation relative aux essais analytiques des médicaments vétérinaires comprend :
\n
1° La composition qualitative et quantitative du médicament ;
\n
2° La description de tous les constituants et du conditionnement primaire ;
\n
3° La description du mode et des conditions de fabrication du médicament ainsi que la formule de fabrication ;
\n
4° La description des techniques de contrôle des matières premières, des produits intermédiaires de la fabrication et du produit fini, la description des techniques de contrôle en cours de fabrication, l'indication des résultats obtenus par application de ces techniques ainsi que les indications utiles sur le conditionnement primaire ;
\n
5° L'indication de la quantité minimale de chaque constituant du médicament et du nombre minimal d'unités de vente qu'il sera nécessaire de prélever pour procéder utilement à des contrôles postérieurs à la délivrance de l'autorisation de mise sur le marché prescrits par le directeur général de l'Agence française de sécurité sanitaire des aliments ;
\n
6° La description des essais de stabilité ayant permis de déterminer la durée proposée de conservation.
" } }, "LEGIARTI000018769246": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "3", "TYPE": "ENTIEREMENT_MODIF", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2999-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000018769246", "URL": "article/LEGI/ARTI/00/00/18/76/92/LEGIARTI000018769246.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000018776034", "@num": "R5141-13", "#text": "Code de la santé publique - art. R5141-13 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018776032", "@num": "R5141-14", "#text": "Code de la santé publique - art. R5141-14 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018776030", "@num": "R5141-15", "#text": "Code de la santé publique - art. R5141-15 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018776026", "@num": "R5141-16", "#text": "Code de la santé publique - art. R5141-16 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018776024", "@num": "R5141-16-1", "#text": "Code de la santé publique - art. R5141-16-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018776021", "@num": "R5141-17", "#text": "Code de la santé publique - art. R5141-17 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018776017", "@num": "R5141-18", "#text": "Code de la santé publique - art. R5141-18 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018776012", "@num": "R5141-19", "#text": "Code de la santé publique - art. R5141-19 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018776007", "@num": "R5141-20", "#text": "Code de la santé publique - art. R5141-20 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018776005", "@num": "R5141-21", "#text": "Code de la santé publique - art. R5141-21 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018776002", "@num": "R5141-22", "#text": "Code de la santé publique - art. R5141-22 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018775997", "@num": "R5141-23", "#text": "Code de la santé publique - art. R5141-23 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915821", "@num": "R5141-24", "#text": "Code de la santé publique - art. R5141-24 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000018767743", "@nor": "SJSP0807006D", "@num": "2008-433", "@nature": "DECRET", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Décret n° 2008-433 du 6 mai 2008 relatif à la mise sur le marché des médicaments vétérinaires", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000018767743", "@c_titre_court": "Décret n°2008-433 du 6 mai 2008" }, { "@fin": "2023-11-25", "#text": "Décret n° 2008-433 du 6 mai 2008 relatif à la mise sur le marché des médicaments vétérinaires", "@debut": "2008-05-08", "@id_txt": "LEGITEXT000018769237", "@c_titre_court": "Décret n°2008-433 du 6 mai 2008" } ], "@ministere": "Ministère de la santé, de la jeunesse, des sports et de la vie associative", "@date_publi": "2008-05-07", "@date_signature": "2008-05-06", "@num_parution_jo": "0107" } }, "VERSIONS": { "VERSION": [ { "LIEN_ART": { "@id": "LEGIARTI000018769246", "@fin": "2999-01-01", "@num": "3", "@debut": "2999-01-01", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000018767760", "@fin": "2999-01-01", "@num": "3", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
A modifié les dispositions suivantes :

- Code de la santé publique
\n Art. R5141-13, Art. R5141-14, Art. R5141-15, Art. R5141-16, Art. R5141-16-1, Art. R5141-17, Art. R5141-18, Art. R5141-19, Art. R5141-20, Art. R5141-21, Art. R5141-22, Art. R5141-23, Art. R5141-24\n
\n

\n
" } }, "LEGIARTI000018776017": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5141-18", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2011-08-29", "DATE_DEBUT": "2008-05-08" } }, "META_COMMUN": { "ID": "LEGIARTI000018776017", "URL": "article/LEGI/ARTI/00/00/18/77/60/LEGIARTI000018776017.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000018769246", "@num": "3", "#text": "Décret n°2008-433\n du 6 mai 2008 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000018767743", "@nortexte": "SJSP0807006D", "@numtexte": "2008-433", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2008-05-06" }, { "@id": "LEGIARTI000025882819", "#text": "Arrêté du 1er septembre 2009 - art. 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Par dérogation au premier alinéa de l'article R. 5141-16, pour les médicaments vétérinaires mentionnés au présent article, le dossier joint à la demande d'autorisation de mise sur le marché est constitué dans les conditions suivantes :
\n
1° Lorsque le demandeur démontre, par référence à une documentation bibliographique appropriée, que la demande porte sur un médicament vétérinaire dont la ou les substances actives sont d'un usage vétérinaire bien établi depuis au moins dix ans en France ou dans la Communauté européenne, le dossier fourni à l'appui de la demande comporte, outre les données pharmaceutiques, la documentation bibliographique appropriée.
\n
Celle-ci peut faire référence, notamment pour ce qui concerne les essais d'innocuité, au rapport d'évaluation publié par l'Agence européenne des médicaments lors d'une demande de fixation de limites maximales de résidus selon les dispositions du règlement (CEE) n° 2377 / 90 du 26 juin 1990.
\n
Lorsque le demandeur a recours à une documentation bibliographique appropriée pour un médicament destiné à une espèce productrice de denrées alimentaires et qu'il accompagne cette documentation, en vue d'obtenir une extension de l'autorisation de mise sur le marché à une autre espèce animale productrice de denrées alimentaires, de nouvelles études de résidus conformément au règlement (CEE) n° 2377 / 90 précité ainsi que de nouveaux essais cliniques, un autre demandeur ne peut se prévaloir de ces études ou essais dans le cadre d'une demande d'autorisation de mise sur le marché pendant une période de trois ans après la délivrance de l'autorisation de mise sur le marché pour laquelle ils ont été réalisés.
\n
2° Lorsque la demande porte sur un médicament vétérinaire nouveau renfermant des substances actives entrant dans la composition de médicaments vétérinaires autorisés, mais qui n'ont pas encore été associés dans un but thérapeutique, le dossier fourni à l'appui de la demande comporte, outre les données pharmaceutiques, les résultats des essais non cliniques et cliniques relatifs à l'association de ces substances sans qu'il soit nécessaire de fournir la documentation non clinique et clinique relative à chaque substance active individuelle.
\n
3° Pour les demandes d'autorisation déposées en application du a, du b et du c de l'article R. 5141-37-3, le dossier fourni à l'appui de la demande comporte, outre les données pharmaceutiques, les résultats des essais non cliniques et cliniques appropriés déterminés en fonction des caractéristiques du médicament considéré.

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D5141-57 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048457242", "@num": "R5141-13", "#text": "Code de la santé publique - art. R5141-13 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915812", "@num": "R5141-15", "#text": "Code de la santé publique - art. R5141-15", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018776021", "@num": "R5141-17", "#text": "Code de la santé publique - art. R5141-17 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000030773933", "@num": "R5141-18", "#text": "Code de la santé publique - art. 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A la demande d'autorisation de mise sur le marché est joint un dossier comprenant :

1° Les informations administratives nécessaires à l'instruction du dossier ;

2° La documentation scientifique démontrant la qualité, la sécurité et l'efficacité du médicament vétérinaire, notamment les rapports d'essais ou d'expérimentations relatifs aux essais pharmaceutiques, non cliniques, cliniques ou d'efficacité, incluant les résultats obtenus au cours de ces différents essais et les rapports d'experts, accompagnés de résumés détaillés et critiques ;

3° La description du système de pharmacovigilance prévu par le futur titulaire de l'autorisation ou par l'entreprise exploitant le médicament vétérinaire et, le cas échéant, du plan de gestion de risque. Le modèle type de plan de gestion de risque est fixé par décision du directeur général de l'Agence française de sécurité sanitaire des aliments ;

4° Les indications thérapeutiques, contre-indications et effets indésirables ;

5° La posologie pour les différentes espèces animales auxquelles le médicament vétérinaire est destiné, forme pharmaceutique, mode et voie d'administration et durée limite d'utilisation ;

6° L'explication des mesures de précaution et de sécurité à prendre lors du stockage du médicament vétérinaire, de son administration aux animaux et de l'élimination des déchets, accompagnées de l'indication des risques potentiels que le médicament vétérinaire pourrait présenter pour l'environnement, la santé humaine et animale et les plantes ;

7° La description des méthodes d'essai utilisées par le fabricant ;

8° Un résumé des caractéristiques du produit, conformément à l'article R. 5141-15, une maquette du conditionnement primaire et de l'emballage extérieur du médicament vétérinaire ainsi que la notice ;

9° Un document dont il ressort que le fabricant est autorisé dans son pays à produire des médicaments vétérinaires ;

10° Une copie des autorisations de mise sur le marché obtenues pour ce médicament vétérinaire dans un autre Etat membre ou dans un pays tiers, ainsi que la liste des Etats membres où la demande d'autorisation soumise en conformité avec la présente directive est à l'examen, accompagnée d'une copie du résumé des caractéristiques du produit proposé par le demandeur ou approuvé par l'autorité compétente de l'Etat membre, ainsi qu'une copie de la notice proposée ;

11° Les détails de toute décision de refus d'autorisation, que ce soit dans la Communauté ou dans un pays tiers et les motifs de cette décision ;

12° La preuve que le demandeur dispose d'une personne qualifiée responsable de la pharmacovigilance et qu'il a les infrastructures nécessaires pour notifier tout effet indésirable présumé survenu, soit dans la Communauté, soit dans un pays tiers ;

13° Dans le cas de médicaments visés au deuxième alinéa de l'article R. 5141-13, une attestation certifiant le dépôt d'une demande valide d'établissement de limites maximales de résidus auprès de l'Agence conformément audit règlement.

Un arrêté des ministres chargés de l'agriculture et de la santé pris sur proposition du directeur de l'Agence française de sécurité sanitaire des aliments précise les modalités selon lesquelles sont établis et présentés les informations et les documents prévus par les articles R. 5141-15 et R. 5141-16.\n

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On entend par :

1° (Abrogé) ;

4° Prémélange médicamenteux, tout médicament vétérinaire préparé à l'avance et exclusivement destiné à la fabrication ultérieure d'aliments médicamenteux ;

6° Médicaments vétérinaires antiparasitaires, tout produit antiparasitaire à usage vétérinaire, ainsi que les produits qui revendiquent une action antiparasitaire externe avec une action létale sur le parasite ;

11° Préparation extemporanée vétérinaire, tout médicament vétérinaire qui est préparé au moment de son utilisation ;

12° Préparation magistrale vétérinaire, toute préparation extemporanée vétérinaire réalisée selon une prescription destinée à un animal ou à des animaux d'une même exploitation ;

14° Temps d'attente, la période nécessaire entre la dernière administration du médicament vétérinaire à l'animal dans les conditions normales d'emploi et l'obtention des denrées alimentaires provenant de cet animal, afin de protéger la santé publique, en garantissant que de telles denrées alimentaires ne contiennent pas de résidus en quantités supérieures aux limites maximales de résidus des substances pharmacologiquement actives, telles que fixées en vertu du règlement du Conseil (CEE) n° 2377 / 90 du 26 juin 1990 modifié établissant une procédure communautaire pour la fixation des limites maximales de résidus de médicaments vétérinaires dans les aliments d'origine animale.

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A la demande d'autorisation de mise sur le marché est joint un dossier comprenant :

1° Les informations administratives nécessaires à l'instruction du dossier ;

4° Les indications thérapeutiques, contre-indications et effets indésirables ;

5° La posologie pour les différentes espèces animales auxquelles le médicament vétérinaire est destiné, forme pharmaceutique, mode et voie d'administration et durée limite d'utilisation ;

7° La description des méthodes d'essai utilisées par le fabricant ;

9° Un document dont il ressort que le fabricant est autorisé dans son pays à produire des médicaments vétérinaires ;

11° Les détails de toute décision de refus d'autorisation, que ce soit dans la Communauté ou dans un pays tiers et les motifs de cette décision ;

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On entend par :

1° (Abrogé) ;

4° Prémélange médicamenteux, tout médicament vétérinaire préparé à l'avance et exclusivement destiné à la fabrication ultérieure d'aliments médicamenteux ;

7° Médicament homéopathique vétérinaire, tout médicament vétérinaire obtenu à partir de substances appelées, souches homéopathiques, selon un procédé de fabrication homéopathique décrit par la pharmacopée européenne, la pharmacopée française ou, à défaut, par les pharmacopées utilisées de façon officielle dans un autre Etat membre de l'Union européenne ; un médicament homéopathique vétérinaire peut aussi contenir plusieurs principes ;

11° Préparation extemporanée vétérinaire, tout médicament vétérinaire qui est préparé au moment de son utilisation ;

12° Préparation magistrale vétérinaire, toute préparation extemporanée vétérinaire réalisée selon une prescription destinée à un animal ou à des animaux d'une même exploitation ;

14° Temps d'attente, la période nécessaire entre la dernière administration du médicament vétérinaire à l'animal dans les conditions normales d'emploi et l'obtention des denrées alimentaires provenant de cet animal, afin de protéger la santé publique, en garantissant que de telles denrées alimentaires ne contiennent pas de résidus en quantités supérieures aux limites maximales de résidus des substances pharmacologiquement actives, telles que fixées en vertu du règlement du Conseil (CEE) n° 2377 / 90 du 26 juin 1990 modifié établissant une procédure communautaire pour la fixation des limites maximales de résidus de médicaments vétérinaires dans les aliments d'origine animale.

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R5146-28 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006196626", "@fin": "2023-11-25", "#text": "Sous-section 1 : Instruction de la demande.", "@debut": "2004-08-08" }, { "@id": "LEGISCTA000048457260", "@fin": "2999-01-01", "#text": "Sous-section 1 : Modification du titulaire", "@debut": "2023-11-25" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006190718", "@fin": "2023-11-25", "#text": "Section 3 : Autorisation de mise sur le marché", "@debut": "2004-08-08" }, { "@id": "LEGISCTA000048457262", "@fin": "2999-01-01", "#text": "Section 3 : Dispositions communes aux médicaments vétérinaires autorisés et enregistrés", "@debut": "2023-11-25" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178661", "@fin": "2999-01-01", "#text": "Chapitre Ier : Dispositions générales", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161014", "@fin": "2999-01-01", "#text": "Titre IV : Médicaments vétérinaires", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145489", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132399", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006112927", "@fin": "2999-01-01", "#text": "Partie réglementaire", "@debut": "2000-12-23" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006915813", "@fin": "2008-05-08", "@num": "R5141-16", "@etat": "MODIFIE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000018776026", "@fin": "2009-06-21", "@num": "R5141-16", "@etat": "MODIFIE", "@debut": "2008-05-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000020775665", "@fin": "2011-04-14", "@num": "R5141-16", "@etat": "MODIFIE", "@debut": "2009-06-21", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000023860648", "@fin": "2023-11-25", "@num": "R5141-16", "@etat": "ABROGE", "@debut": "2011-04-14", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

A la demande d'autorisation de mise sur le marché est joint un dossier comprenant :

1° Les informations administratives nécessaires à l'instruction du dossier ;

4° Les indications thérapeutiques, contre-indications et effets indésirables ;

5° La posologie pour les différentes espèces animales auxquelles le médicament vétérinaire est destiné, forme pharmaceutique, mode et voie d'administration et durée limite d'utilisation ;

7° La description des méthodes d'essai utilisées par le fabricant ;

9° Un document dont il ressort que le fabricant est autorisé dans son pays à produire des médicaments vétérinaires ;

11° Les détails de toute décision de refus d'autorisation, que ce soit dans la Communauté ou dans un pays tiers et les motifs de cette décision ;

Un arrêté des ministres chargés de l'agriculture et de la santé pris sur proposition du directeur de l'Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail précise les modalités selon lesquelles sont établis et présentés les informations et les documents prévus par le présent article.\n

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On entend par :

1° (Abrogé) ;

4° Prémélange médicamenteux, tout médicament vétérinaire préparé à l'avance et exclusivement destiné à la fabrication ultérieure d'aliments médicamenteux ;

7° Médicament homéopathique vétérinaire, tout médicament vétérinaire obtenu à partir de substances appelées, souches homéopathiques, selon un procédé de fabrication homéopathique décrit par la pharmacopée européenne, la pharmacopée française ou, à défaut, par les pharmacopées utilisées de façon officielle dans un autre Etat membre de l'Union européenne ; un médicament homéopathique vétérinaire peut aussi contenir plusieurs principes ;

11° Préparation extemporanée vétérinaire, tout médicament vétérinaire qui est préparé au moment de son utilisation ;

12° Préparation magistrale vétérinaire, toute préparation extemporanée vétérinaire réalisée selon une prescription destinée à un animal ou à des animaux d'une même exploitation ;

14° Temps d'attente, la période nécessaire entre la dernière administration du médicament vétérinaire à l'animal dans les conditions normales d'emploi et l'obtention des denrées alimentaires provenant de cet animal, afin de protéger la santé publique, en garantissant que de telles denrées alimentaires ne contiennent pas de résidus en quantités supérieures aux limites maximales de résidus des substances pharmacologiquement actives, telles que fixées en vertu du règlement (CE) n° 470/2009 du Parlement européen et du Conseil du 6 mai 2009 établissant des procédures communautaires pour la fixation des limites de résidus des substances pharmacologiquement actives dans les aliments d'origine animale.

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R5141-80 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800810", "@num": "R5146-29", "#text": "Code de la santé publique - art. R5146-29 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800807", "@num": "R5146-29", "#text": "Code de la santé publique - art. R5146-29 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006196626", "@fin": "2023-11-25", "#text": "Sous-section 1 : Instruction de la demande.", "@debut": "2004-08-08" }, { "@id": "LEGISCTA000048457260", "@fin": "2999-01-01", "#text": "Sous-section 1 : Modification du titulaire", "@debut": "2023-11-25" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006190718", "@fin": "2023-11-25", "#text": "Section 3 : Autorisation de mise sur le marché", "@debut": "2004-08-08" }, { "@id": "LEGISCTA000048457262", "@fin": "2999-01-01", "#text": "Section 3 : Dispositions communes aux médicaments vétérinaires autorisés et enregistrés", "@debut": "2023-11-25" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178661", "@fin": "2999-01-01", "#text": "Chapitre Ier : Dispositions générales", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161014", "@fin": "2999-01-01", "#text": "Titre IV : Médicaments vétérinaires", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145489", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132399", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006112927", "@fin": "2999-01-01", "#text": "Partie réglementaire", "@debut": "2000-12-23" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006915815", "@fin": "2008-05-08", "@num": "R5141-18", "@etat": "MODIFIE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000018776017", "@fin": "2011-08-29", "@num": "R5141-18", "@etat": "MODIFIE", "@debut": "2008-05-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000024516430", "@fin": "2014-02-01", "@num": "R5141-18", "@etat": "MODIFIE", "@debut": "2011-08-29", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000027859857", "@fin": "2015-06-25", "@num": "R5141-18", "@etat": "MODIFIE", "@debut": "2014-02-01", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000030773933", "@fin": "2023-11-25", "@num": "R5141-18", "@etat": "ABROGE", "@debut": "2015-06-25", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

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1° Lorsque le demandeur démontre, par référence à une documentation bibliographique appropriée, que la demande porte sur un médicament vétérinaire dont la ou les substances actives sont d'un usage vétérinaire bien établi depuis au moins dix ans en France ou dans la Communauté européenne, le dossier fourni à l'appui de la demande comporte, outre les données pharmaceutiques, la documentation bibliographique appropriée.

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Celle-ci peut faire référence, notamment pour ce qui concerne les essais d'innocuité, au rapport d'évaluation publié par l'Agence européenne des médicaments lors d'une demande de fixation de limites maximales de résidus selon les dispositions du règlement (CE) n° 470/2009 du Parlement européen et du Conseil du 6 mai 2009 établissant des procédures communautaires pour la fixation des limites de résidus des substances pharmacologiquement actives dans les aliments d'origine animale.

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Lorsque le demandeur a recours à une documentation bibliographique appropriée pour un médicament destiné à une espèce productrice de denrées alimentaires et qu'il accompagne cette documentation, en vue d'obtenir une extension de l'autorisation de mise sur le marché à une autre espèce animale productrice de denrées alimentaires, de nouvelles études de résidus conformément au règlement (CE) n° 470/2009 du Parlement européen et du Conseil du 6 mai 2009 mentionné à l'alinéa précédent ainsi que de nouveaux essais cliniques, un autre demandeur ne peut se prévaloir de ces études ou essais dans le cadre d'une demande d'autorisation de mise sur le marché pendant une période de trois ans après la délivrance de l'autorisation de mise sur le marché pour laquelle ils ont été réalisés.

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2° Lorsque la demande porte sur un médicament vétérinaire nouveau renfermant des substances actives entrant dans la composition de médicaments vétérinaires autorisés, mais qui n'ont pas encore été associés dans un but thérapeutique, le dossier fourni à l'appui de la demande comporte, outre les données pharmaceutiques, les résultats des essais non cliniques et cliniques relatifs à l'association de ces substances sans qu'il soit nécessaire de fournir la documentation non clinique et clinique relative à chaque substance active individuelle.

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3° Pour les demandes d'autorisation déposées en application du a, du b et du c de l'article R. 5141-37-3, le dossier fourni à l'appui de la demande comporte, outre les données pharmaceutiques, les résultats des essais non cliniques et cliniques appropriés déterminés en fonction des caractéristiques du médicament considéré.

" } }, "LEGIARTI000027859857": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5141-18", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2015-06-25", "DATE_DEBUT": "2014-02-01" } }, "META_COMMUN": { "ID": "LEGIARTI000027859857", "URL": "article/LEGI/ARTI/00/00/27/85/98/LEGIARTI000027859857.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000025882819", "#text": "Arrêté du 1er septembre 2009 - art. 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R5141-80 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800810", "@num": "R5146-29", "#text": "Code de la santé publique - art. R5146-29 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800807", "@num": "R5146-29", "#text": "Code de la santé publique - art. R5146-29 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006196626", "@fin": "2023-11-25", "#text": "Sous-section 1 : Instruction de la demande.", "@debut": "2004-08-08" }, { "@id": "LEGISCTA000048457260", "@fin": "2999-01-01", "#text": "Sous-section 1 : Modification du titulaire", "@debut": "2023-11-25" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006190718", "@fin": "2023-11-25", "#text": "Section 3 : Autorisation de mise sur le marché", "@debut": "2004-08-08" }, { "@id": "LEGISCTA000048457262", "@fin": "2999-01-01", "#text": "Section 3 : Dispositions communes aux médicaments vétérinaires autorisés et enregistrés", "@debut": "2023-11-25" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178661", "@fin": "2999-01-01", "#text": "Chapitre Ier : Dispositions générales", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161014", "@fin": "2999-01-01", "#text": "Titre IV : Médicaments vétérinaires", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145489", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132399", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006112927", "@fin": "2999-01-01", "#text": "Partie réglementaire", "@debut": "2000-12-23" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006915815", "@fin": "2008-05-08", "@num": "R5141-18", "@etat": "MODIFIE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000018776017", "@fin": "2011-08-29", "@num": "R5141-18", "@etat": "MODIFIE", "@debut": "2008-05-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000024516430", "@fin": "2014-02-01", "@num": "R5141-18", "@etat": "MODIFIE", "@debut": "2011-08-29", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000027859857", "@fin": "2015-06-25", "@num": "R5141-18", "@etat": "MODIFIE", "@debut": "2014-02-01", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000030773933", "@fin": "2023-11-25", "@num": "R5141-18", "@etat": "ABROGE", "@debut": "2015-06-25", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

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1° Lorsque le demandeur démontre, par référence à une documentation bibliographique appropriée, que la demande porte sur un médicament vétérinaire dont la ou les substances actives sont d'un usage vétérinaire bien établi depuis au moins dix ans en France ou dans l'Union européenne, le dossier fourni à l'appui de la demande comporte, outre les données pharmaceutiques, la documentation bibliographique appropriée.

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\n

" } }, "LEGIARTI000030773933": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5141-18", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2023-11-25", "DATE_DEBUT": "2015-06-25" } }, "META_COMMUN": { "ID": "LEGIARTI000030773933", "URL": "article/LEGI/ARTI/00/00/30/77/39/LEGIARTI000030773933.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000025882819", "#text": "Arrêté du 1er septembre 2009 - art. 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1° Lorsque le demandeur démontre, par référence à une documentation bibliographique appropriée, que la demande porte sur un médicament vétérinaire dont la ou les substances actives sont d'un usage vétérinaire bien établi depuis au moins dix ans en France ou dans l'Union européenne, le dossier fourni à l'appui de la demande comporte, outre les données pharmaceutiques, la documentation bibliographique appropriée.

3° Pour les demandes d'extensions telles que définies au 4° de l'article 2 du règlement (CE) n° 1234/2008 de la Commission du 28 novembre 2008 concernant l'examen des modifications des termes d'une autorisation de mise sur le marché de médicaments à usage humain et de médicaments vétérinaires, le dossier fourni à l'appui de la demande comporte, outre les données pharmaceutiques, les résultats des essais non cliniques et cliniques appropriés déterminés en fonction des caractéristiques du médicament considéré.

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I.-Les médicaments vétérinaires mentionnés au présent chapitre sont ceux définis à l'article 4 du règlement (UE) 2019/6 du 11 décembre 2018 et au présent article.
\n
\n II.-On entend par :
\n
\n 1° Préparation extemporanée vétérinaire, tout médicament vétérinaire qui n'est pas préparé à l'avance et qui répond aux conditions fixées au b ou au c du paragraphe 6 de l'article 2 du règlement (UE) 2019/6 du 11 décembre 2018 ;
\n
\n 2° Préparation magistrale vétérinaire, toute préparation extemporanée réalisée soit par une personne autorisée visée à l'article L. 5143-2, soit dans des conditions prévues à l'article L. 5143-9-1 conformément à une ordonnance vétérinaire, pour un animal déterminé ou un petit groupe d'animaux tel que défini au b du paragraphe 6 de l'article 2 du règlement (UE) 2019/6 du 11 décembre 2018 ;
\n
\n 3° Préparation officinale vétérinaire, toute préparation réalisée en pharmacie conformément aux instructions d'une pharmacopée et destinée à être délivrée directement à l'utilisateur final.

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R5141-49 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048457296", "@num": "R5141-5", "#text": "Code de la santé publique - art. R5141-5 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033240288", "@num": "R5141-50", "#text": "Code de la santé publique - art. R5141-50 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048454984", "@num": "R5141-61", "#text": "Code de la santé publique - art. R5141-61 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048454986", "@num": "R5141-61-1", "#text": "Code de la santé publique - art. R5141-61-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048454988", "@num": "R5141-61-2", "#text": "Code de la santé publique - art. R5141-61-2 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048454990", "@num": "R5141-61-3", "#text": "Code de la santé publique - art. R5141-61-3 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048454992", "@num": "R5141-61-4", "#text": "Code de la santé publique - art. R5141-61-4 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048454994", "@num": "R5141-61-5", "#text": "Code de la santé publique - art. R5141-61-5 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048457229", "@num": "R5141-62", "#text": "Code de la santé publique - art. R5141-62 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000027859923", "@num": "R5141-63", "#text": "Code de la santé publique - art. R5141-63 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018776120", "@num": "R5141-64", "#text": "Code de la santé publique - art. R5141-64 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048457226", "@num": "R5141-65", "#text": "Code de la santé publique - art. R5141-65 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048457220", "@num": "R5141-66", "#text": "Code de la santé publique - art. R5141-66 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000027859921", "@num": "R5141-66-1", "#text": "Code de la santé publique - art. R5141-66-1 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048457214", "@num": "R5141-67", "#text": "Code de la santé publique - art. R5141-67 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048457208", "@num": "R5141-68", "#text": "Code de la santé publique - art. R5141-68 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000023860124", "@num": "R5141-69", "#text": "Code de la santé publique - art. R5141-69 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915861", "@num": "R5141-7", "#text": "Code de la santé publique - art. R5141-7 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048457203", "@num": "R5141-70", "#text": "Code de la santé publique - art. R5141-70 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033365715", "@num": "R5141-71", "#text": "Code de la santé publique - art. R5141-71 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048457198", "@num": "R5141-72", "#text": "Code de la santé publique - art. R5141-72 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "DEPLACE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000023860640", "@num": "R5141-73", "#text": "Code de la santé publique - art. R5141-73 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048457189", "@num": "R5141-74", "#text": "Code de la santé publique - art. R5141-74 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915889", "@num": "R5141-75", "#text": "Code de la santé publique - art. R5141-75 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000030714435", "@num": "R5141-76", "#text": "Code de la santé publique - art. R5141-76 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018776129", "@num": "R5141-77", "#text": "Code de la santé publique - art. R5141-77 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915895", "@num": "R5141-78", "#text": "Code de la santé publique - art. R5141-78 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000023860634", "@num": "R5141-79", "#text": "Code de la santé publique - art. R5141-79 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048457286", "@num": "R5141-8", "#text": "Code de la santé publique - art. R5141-8 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048457184", "@num": "R5141-80", "#text": "Code de la santé publique - art. R5141-80 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000027859918", "@num": "R5141-81", "#text": "Code de la santé publique - art. R5141-81 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048457179", "@num": "R5141-82", "#text": "Code de la santé publique - art. R5141-82 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000030714471", "@num": "R5141-82-1", "#text": "Code de la santé publique - art. R5141-82-1 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048457173", "@num": "R5141-83", "#text": "Code de la santé publique - art. R5141-83 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048457167", "@num": "R5141-84", "#text": "Code de la santé publique - art. R5141-84 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000030713511", "@num": "R5141-85-1", "#text": "Code de la santé publique - art. R5141-85-1 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048457162", "@num": "R5141-85-2", "#text": "Code de la santé publique - art. R5141-85-2 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000030713515", "@num": "R5141-85-3", "#text": "Code de la santé publique - art. R5141-85-3 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048457158", "@num": "R5141-86", "#text": "Code de la santé publique - art. R5141-86 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048457153", "@num": "R5141-86-1", "#text": "Code de la santé publique - art. R5141-86-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000030713596", "@num": "R5141-86-2", "#text": "Code de la santé publique - art. R5141-86-2 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048457148", "@num": "R5141-87", "#text": "Code de la santé publique - art. R5141-87 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048457143", "@num": "R5141-88", "#text": "Code de la santé publique - art. R5141-88 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018095518", "@num": "R5141-89", "#text": "Code de la santé publique - art. R5141-89 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048457281", "@num": "R5141-9", "#text": "Code de la santé publique - art. R5141-9 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018095514", "@num": "R5141-90", "#text": "Code de la santé publique - art. R5141-90 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915916", "@num": "R5141-91", "#text": "Code de la santé publique - art. R5141-91 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018095510", "@num": "R5141-92", "#text": "Code de la santé publique - art. R5141-92 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048457139", "@num": "R5141-93", "#text": "Code de la santé publique - art. R5141-93 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048457128", "@num": "R5141-94", "#text": "Code de la santé publique - art. R5141-94 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048457118", "@num": "R5141-95", "#text": "Code de la santé publique - art. R5141-95 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000027859913", "@num": "R5141-96", "#text": "Code de la santé publique - art. R5141-96 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000027859911", "@num": "R5141-96-1", "#text": "Code de la santé publique - art. R5141-96-1 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "dispositions du chapitre IV du titre III du livre II du code rural et de la pêche maritime", "@sens": "source", "@typelien": "CITATION" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000048453209", "@nor": "AGRG2318778D", "@num": "2023-1079", "@nature": "DECRET", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Décret n° 2023-1079 du 22 novembre 2023 portant adaptation des dispositions du code de la santé publique et du code rural et de la pêche maritime au droit de l'Union européenne dans le domaine des médicaments vétérinaires", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000048453209", "@c_titre_court": "Décret n°2023-1079 du 22 novembre 2023" }, { "@fin": "2999-01-01", "#text": "Décret n° 2023-1079 du 22 novembre 2023 portant adaptation des dispositions du code de la santé publique et du code rural et de la pêche maritime au droit de l'Union européenne dans le domaine des médicaments vétérinaires", "@debut": "2023-11-25", "@id_txt": "LEGITEXT000048454135", "@c_titre_court": "Décret n°2023-1079 du 22 novembre 2023" } ], "@ministere": "Ministère de l'agriculture et de la souveraineté alimentaire", "@date_publi": "2023-11-24", "@date_signature": "2023-11-22", "@num_parution_jo": "0272" } }, "VERSIONS": { "VERSION": [ { "LIEN_ART": { "@id": "LEGIARTI000048454147", "@fin": "2999-01-01", "@num": "1", "@debut": "2999-01-01", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000048453218", "@fin": "2999-01-01", "@num": "1", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
A abrogé les dispositions suivantes :

- Code de la santé publique
\n Sct. Section 1 : Définitions., Art. R5141-1, Art. R5141-1-1, Art. R5141-7, Art. R5141-12, Art. R5141-13-1, Art. R5141-16, Art. R5141-16-1, Art. R5141-17, Art. R5141-18, Art. R5141-19, Art. R5141-20, Art. R5141-21, Art. R5141-22, Art. R5141-23, Art. R5141-25, Sct. Sous-section 3 : Modalités d'autorisation., Art. R5141-26, Art. R5141-27, Art. R5141-28, Art. R5141-29, Art. R5141-34, Art. R5141-34-1, Art. R5141-35, Art. R5141-36, Art. R5141-37, Art. R5141-38, Art. R5141-39, Art. R5141-39-1, Art. R5141-40, Art. R5141-41, Art. R5141-42, Art. R5141-44, Art. R5141-45, Art. R5141-47, Sct. Sous-section 3 bis : Procédure de reconnaissance mutuelle et procédure décentralisée., Sct. Paragraphe 1 : Dispositions générales., Art. R5141-47-1, Sct. Paragraphe 2 : Procédure de reconnaissance mutuelle., Art. R5141-47-2, Art. R5141-47-3, Sct. Paragraphe 3 : Procédure décentralisée., Art. R5141-47-4, Sct. Paragraphe 4 : Dispositions communes aux deux procédures., Art. R5141-47-5, Art. R5141-47-6, Art. R5141-47-7, Art. R5141-47-8, Sct. Paragraphe 5 : Autres applications de la procédure d'arbitrage communautaire., Art. R5141-47-9, Art. R5141-47-10, Art. R5141-47-11, Art. R5141-47-12, Sct. Sous-section 4 : Etudes post-autorisation, Art. R5141-48, Art. R5141-49, Art. R5141-50, Art. R5141-63, Art. R5141-64, Art. R5141-66-1, Art. R5141-69, Art. R5141-71, Art. R5141-73, Art. R5141-75, Sct. Section 6 : Notice., Art. R5141-76, Art. R5141-77, Art. R5141-78, Art. R5141-79, Art. R5141-81, Art. R5141-82-1, Art. R5141-85-1, Art. R5141-85-3, Art. R5141-86-2, Art. R5141-89, Art. R5141-90, Art. R5141-91, Art. R5141-92, Art. R5141-96, Art. R5141-96-1, Art. R5141-104, Art. R5141-105, Art. R5141-105-1, Art. R5141-105-2, Art. R5141-107, Art. R5141-108, Art. R5141-109\n
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A créé les dispositions suivantes :

- Code de la santé publique
\n Sct. Sous-section 1 : Enregistrement de médicaments vétérinaires destinés exclusivement aux animaux de compagnie mentionnés à l'article L. 5141-5-1, Sct. Sous-section 2 : Enregistrement des médicaments homéopathiques, Art. R5141-61, Art. R5141-61-1, Art. R5141-61-2, Art. R5141-61-3, Art. R5141-61-4, Art. R5141-61-5\n
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A modifié les dispositions suivantes :

- Code de la santé publique
\n Art. R5141-2, Art. R5141-3, Art. R5141-4, Art. R5141-5, Art. R5141-8, Art. R5141-9, Art. R5141-10, Art. R5141-11, Sct. Section 3 : Dispositions communes aux médicaments vétérinaires autorisés et enregistrés, Sct. Sous-section 1 : Modification du titulaire, Sct. Sous-section 2 : Publicité des décisions et recours préalable obligatoire, Art. R5141-13, Art. R5141-14, Art. R5141-15, Sct. Section 4 : Dispositions spécifiques à certains médicaments vétérinaires, Art. R5141-62, Art. R5141-65, Art. R5141-66, Art. R5141-67, Art. R5141-68, Art. R5141-70, Art. R5141-72, Sct. Section 5 : Mise à disposition de la notice, Art. R5141-74, Art. R5141-80, Art. R5141-82, Art. R5141-83, Art. R5141-84, Art. R5141-85-2, Art. R5141-86, Art. R5141-86-1, Art. R5141-87, Art. R5141-88, Art. R5141-93, Art. R5141-94, Art. R5141-95, Art. R5141-101, Art. R5141-103, Art. R5141-106, Art. R5141-110\n
\n

\n
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Article R5141-19 AUTONOME ABROGE, en vigueur du 08/05/2008 au 25/11/2023 (Code de la santé publique)